| Trial ID: | L6287 |
| Source ID: | NCT06084156
|
| Associated Drug: |
Hsk7653
|
| Title: |
A Study to Evaluate the DDI of HSK7653 With Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: HSK7653|DRUG: Metformin
|
| Outcome Measures: |
Primary: The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects., Day4, day 27 and day 41|The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects., Day4, day 27 and day 41 | Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), First dose of study drug up to 62 days after last dose of study drug|Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated, Day 41
|
| Sponsor/Collaborators: |
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-08-10
|
| Completion Date: |
2019-12-09
|
| Results First Posted: |
|
| Last Update Posted: |
2023-10-16
|
| Locations: |
Peking University Third Hospital, Beijing, Beijing, 100191, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06084156
|